Streamlining electronic reporting of serious adverse events (SAEs) using the REDCap data collection system: the eSAE Project.

The eSAE Project coded into REDCap offers a unique way of populating SAE forms with information already entered in the initial AE forms as applicable, coupled with highlighting any updates during the lifetime of the SAE for sponsors to identify any new information that needs to be reassessed to process and report the SAE.